猫血清中总甲状腺素定量测定的即时护理试验的评价。

IF 1.9 2区 农林科学 Q2 VETERINARY SCIENCES
Eva Spada, Roberta Perego, Luciana Baggiani, Daniela Proverbio
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引用次数: 0

摘要

目的:总甲状腺素(TT4)评估是诊断和监测猫甲状腺功能亢进最常用的一线测试。Vcheck T4是一种即时免疫分析法,使用Vcheck V200分析仪测量TT4。本研究旨在评价Vcheck T4测定法在猫血清中的分析性能,以及Vcheck T4正常、高、低TT4浓度分类与酶免疫测定法(EIA)的一致性。方法:对Vcheck T4进行精密度、重现性和线性评价。为进行方法比较,采用两种方法对73份血清样品进行TT4浓度分析。结果:Vcheck T4在8 μg/dl的诊断范围内具有良好的精密度、重复性(检测内和检测间变异系数在3% ~ 13.5%之间)和线性关系。相关系数为0.87,Passing-Bablok回归显示成比例偏差,但不存在恒定偏差,Bland-Altman图显示平均差为+0.5 μg/dl。TT4 EIA和Vcheck结果之间的总体评分一致性(K = 0.69)很大,一致性为82.2%。作为甲状腺功能亢进的诊断试验,Vcheck T4的敏感性和特异性分别为88.9%和84.4%,阳性预测值(PPV)和阴性预测值(NPV)分别为44.5%和98.2%。结论和相关性:Vcheck T4检测提供了与EIA基本一致的精确和可重复的结果。鉴于高净现值,Vcheck T4在筛查猫时有助于排除甲状腺功能亢进,但基于低PPV,高TT4结果的样本需要采用另一种参考方法进行分析。需要对溶血、黄疸和血脂样本进行进一步分析,以评估测试的性能。最后,制造商提供的参考区间需要验证,在未来的研究中必须建立针对该方法的TT4区间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of a point-of-care test for quantitative determination of total thyroxine in feline serum.

Objectives: Total thyroxine (TT4) evaluation is the most commonly used first-line test for the diagnosis and monitoring of cats with hyperthyroidism. Vcheck T4 is a point-of-care immunoassay that measures TT4 using a Vcheck V200 analyser. This study aimed to evaluate the analytic performance of the Vcheck T4 assay in feline sera and the agreement in the classification of normal, high and low TT4 concentrations of Vcheck T4 with those measured by an enzyme immunoassay (EIA).

Methods: Assay precision, reproducibility and linearity were evaluated for the Vcheck T4. For method comparison, TT4 concentrations in 73 serum samples were analysed by both methods.

Results: Vcheck T4 demonstrated good precision, reproducibility (intra- and inter-assay coefficients of variation between 3% and 13.5%) and linearity in the diagnostic range of <0.5 and >8 μg/dl. The correlation coefficient was 0.87, Passing-Bablok regression showed a proportional, but not constant bias, Bland-Altman plots revealed a mean difference of +0.5 μg/dl. The overall inter-rater agreement (K) between TT4 EIA and Vcheck results was substantial (K = 0.69), with 82.2% of concordant results. As a diagnostic test for hyperthyroidism, Vcheck T4 showed a sensitivity and specificity of 88.9% and 84.4%, and a positive predictive value (PPV) and negative predictive value (NPV) of 44.5% and 98.2%, respectively.

Conclusions and relevance: Vcheck T4 assay provided precise and reproducible results in substantial agreement with the EIA. Given the high NPV, Vcheck T4 is useful in ruling out hyperthyroidism when screening cats, but, based on low PPV, samples with results with high TT4 need to be analysed by another reference method. Further analysis with haemolytic, icteric and lipaemic samples is needed to assess the test performance. Finally, the reference intervals provided by the manufacturer require verification, and TT4 intervals specific to this method must be established in future studies.

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来源期刊
CiteScore
3.90
自引率
17.60%
发文量
254
审稿时长
8-16 weeks
期刊介绍: JFMS is an international, peer-reviewed journal aimed at both practitioners and researchers with an interest in the clinical veterinary healthcare of domestic cats. The journal is published monthly in two formats: ‘Classic’ editions containing high-quality original papers on all aspects of feline medicine and surgery, including basic research relevant to clinical practice; and dedicated ‘Clinical Practice’ editions primarily containing opinionated review articles providing state-of-the-art information for feline clinicians, along with other relevant articles such as consensus guidelines.
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